"Pain Relief for Office Hysteroscopy: A Randomized Controlled Trial Comparing a Transcutaneous Electric Nerve Stimulation and Placebo
Description
Abstract Background: The efficacy of transcutaneous electrical nerve stimulation (TENS) as a non-invasive method for pain management during office-based hysteroscopy requires additional investigation. Objective: To evaluate the analgesic effects of transcutaneous electrical nerve stimulation (TENS) in office hysteroscopy procedures and the level of patient satisfaction with this intervention. Patients and Methods: The study employed a double-blind randomized controlled trial design, which included a sample of 120 female participants who underwent office hysteroscopy. The participants were categorized into two groups: the TENS group (N = 60) received active transcutaneous electrical nerve stimulation (TENS) during office hysteroscopy using a health tronic alpha wave TENS instrument (Model MB - 1004) with four large pads, two channels, two leads, a pulse width of 200 µs, and a pulse frequency ranging from 40 to 100 Hz. The Placebo group (N = 60) received placebo TENS during office hysteroscopy. Results: Following the hysteroscopy procedure at the office, both the TENS and placebo study groups exhibited comparable levels of pain, with no statistically significant differences observed in terms of the Visual Analogue Scale (VAS) assessment (p = 0.311) and the intensity of pain (p = 0.11). No statistically significant difference was seen in the satisfaction rating between the two groups when using the verbal Likert scale (p = 0.351). The study found a significant positive correlation between the VAS score and the age (r = 0.256, P <0.001) as well as the parity (r = 0.404, p <0.001). Conversely, a negative correlation was seen between the VAS score and the participants' height (r = -0.317, p <0.001) and Likert verbal scale (r = -0.278, p <0.001). Conclusion: The TENS device does not provide a substantial alleviation of the pain linked to office hysteroscopy Keywords: Hysteroscopy, TENS, Pain.
Files
Steps to reproduce
This study employed a double-blind randomized controlled design and included 120 female patients who underwent office hysteroscopy at the Early Cancer Detection & Gyn Endoscopy Unit of Ain Shams Maternity University Hospital. The study took place from March 2019 to July 2019. The research was officially registered on the ClinicalTrials.gov platform, using the unique identifier NCT04229576. The investigation involved female patients who satisfied the inclusion criteria, including being between the ages of 21 and 74, experiencing leiomyoma or endometrial polyps, having postmenopausal hemorrhage with thick endometrial lining, experiencing menstrual disturbance, or suspected uterine deformity. Exclusion criteria for this trial encompassed women who had unexplained vaginal hemorrhage, neurological impairments, opioid or psychotropic drug usage, either preprocedural or chronic, prior transcutaneous electrical nerve stimulation (TENS) experience, automatically implanted pacemakers, or cardiac defibrillators. The patients were randomly assigned to two groups of equal size, as outlined below: Group 1, referred to as the study group, consisted of 60 patients who received Active TENS during office hysteroscopy. On the other hand, group 2, known as the control group, consisted of 60 patients who received Placebo TENS. In the Placebo TENS group, participants were connected to the TENS unit in the same manner as those in the active TENS group. However, during office hysteroscopy, the unit emitted the active indicator light and sound, but did not provide any electrical stimulation. Every patient received a Upon arrival, a comprehensive clinical examination was conducted, and a meticulous medical history was acquired (Figure 1). The allocation concealment mechanism involves the utilization of consecutive numbers on opaque sealed envelopes. These envelopes are assigned a letter of either "A" or "B" based on a sequence generated through a computer-generated process. Each envelope contains a letter that corresponds to a number in the randomization list. The allocation of participating women to each group was based on the letter included within the envelope. The TENS intervention, also known as the active TENS instrument. The Healthtronic Alpha Wave is equipped with four spacious pads, two channels, and two leads. It has a pulse width of 200 µs and a pulse frequency ranging from 40 to 100 Hz. The MB-1004 model included a variable high-frequency range of 80-100 Hz with a pulse duration of 400 microseconds. The application of TENS treatment commenced 5 minutes before to the hysteroscopy procedure and persisted throughout the entire operation. Two sets of self-adhesive electrodes (circular pads) were inserted parallel to the spinal cord at the T10-L1 and S2-S4 levels.
Institutions
Categories
Funding
Non to declare